• Patient inclusion/exclusion criteria - subjects listed as screened and nonqualifying
• Concomitant medications - the use of concomitant medications not approved in the protocol
• Adverse reactions - failure of the sponsor/investigator to report these observations on the contract report and transmit this information to the IRB and, when applicable, to the FDA
• Data entry problems - required data not entered on or missing on the contract report form; laboratory data incomplete or abnormal lab results not commented as required by the protocol
• Informing the sponsor that the study is not acceptable in a support of claims of efficacy in an application for research or marketing permit
• Sponsor inspection including termination of the IND application
• Initiation of the disqualification procedures or entry into a consent agreement with the clinical investigator
• Initiation of stock recovery by the sponsor
• Seizure of test articles if not exempted by regulation
The number of warning letters, NIDPOE letters and FDA action leading to investigator disqualification is illustrated in Table 7.1.
Was this article helpful?